The Challenge

A large mid-western Medical Device company responding to multiple FDA inspections had not made adequate progress towards remediating their quality systems.  The company had several hundred products that required remediation and a deadline of 18 months to complete this work.

The Solution

Performance Validation provided a dedicated consultant who participated with the client’s management team.  The team provided guidance and direction to the company necessary to complete this work on schedule.

  • Provided guidance and direction in the development of the following:
    • Family approach to complete the process validation remediation.  Identified/ documented the quality data to be reviewed to select representative products from the family.
    • Formal process characterization document which provided consistency in process characterization and documented characterization reports.
    • Formal method to identify the Critical Quality Attributes and Critical Process Parameters for the various manufacturing and dispensing processes.  Re-instituted the use of the Process Specification document which captured the output from the CQA and CPP studies.
  • Revised the validation program to include:
    • Verification that Process Characterization is complete and suitable for use in the manufacturing environment.  Integration of equipment Qualification to process requirements (formal verification that the equipment is suitable for its intended purpose in the process).
    • Verification that the parameters (CPP) that have an impact on the process output (CQA) are formally identified and traceable to specific tests.
    • Revision of the site Validation Master Plan to better address the integration of Commissioning, equipment qualification, process validation.  Provided greater clarity on the validation lifecycle and how specifications, characterization, qualification and validation are related.
  • Implementation of a validation consultant group (personnel with greater than 10 years of validation experience) as a temporary measure to assist in the pre and post execution review of validation documents.  This team provided insight and guidance to the validation engineers authoring documents and the management team approving the documents.

The Results

  • The various products were successfully grouped into product families and representatives that would be subject to process validation were chosen based on key criteria.
  • Process characterization was completed and the CQA and CPP’s were identified and carried forward into the validation program.
  • Family process validations were essentially complete January 09.
  • Satisfactorily completed Internal audit February 09.

The Benefits

  • The completed project accomplished the following for the manufacturing facility:
  • Met an FDA commitment to complete process validations by target date.
  • Improved process and manufacturing process knowledge, revising the manufacturing batch records and reducing scrap.
  • Improved knowledge and understanding of the validation process.

For more information concerning PV’s Medical Device Quality System Improvements and Process Remediation capabilities, please schedule a call with one of our subject matter experts. 

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